Screening practices and risk assessment for maculopathy in pentosan polysulfate users across different exposure levels

Kwon HY, Kim J, Ahn SJ · Scientific Reports

Maculopathy risk rose with cumulative dose: adjusted hazard ratios of 1.55 (50–500 g) and 1.66 (500 g or more) against minimal exposure, and cumulative incidence of maculopathy excluding common macular diseases of 9.0%, 6.4% and 4.3% across the three groups. The screening finding is the sharper one: high-exposure users were monitored no more often than low-exposure users (52.6% vs 49.4%, p = 0.156), so nearly half of the people the authors define as high-risk went unexamined.

Population

133,762 South Koreans starting oral PPS 2012–2021, nationwide claims database

Intervention

Oral PPS, stratified by cumulative dose: under 50 g, 50–500 g, and 500 g or more

Comparator

The minimal-exposure (<50 g) group

Limitations

Claims-code diagnoses without image review, and the toxic-maculopathy code itself was only available to 2020, so the authors widened the outcome to broader macular conditions. The headline cohort is every PPS user; the high-exposure group is 445 people, 0.3% of it, and the 1.66 rests on them. 500 g of cumulative exposure equals roughly four and a half years of standard daily oral dosing, orders of magnitude beyond any injection course.